Trial Information

- Identify tumor antigens that induce a humoral response in patients with cancer.

- Identify tumor-secreted proteins by special analysis in culture, and evaluate their
expression patterns in tumors and preneoplastic lesions to further assess their
potential specificity.

- Determine serum positivity and specificity of potential markers for early detection of
cancer.

OUTLINE: This is a multicenter study.

Patients and healthy participants undergo blood collection. Patients with suspected or newly
diagnosed disease undergo a second blood collection between 4-10 weeks after surgery (but
before any additional cytotoxic therapy or radiotherapy) provided they had a surgical
resection with negative margin. All patients are asked questions about family history of
cancer, the development of their cancer, other medical history, past and present smoking
history, and menstrual period for females.

DNA is extracted from the blood and from patient tumor tissue samples obtained during
surgery. Immunohistochemistry (including polymerase chain reaction) and in situ
hybridization are used to analyze protein expression patterns, after proteins are identified
by mass spectrometry and amino acid sequencing.

PROJECTED ACCRUAL: A total of 3,150 patients and 1,200 healthy participants will be accrued
for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria (patient):

- Scheduled to undergo primary surgical resection or first debulking surgery
(prior to any anticancer treatment) for suspected or newly diagnosed cancer,
including any of the following types:

- Breast cancer

- Adenocarcinoma of the colon

- Adenocarcinoma or squamous cell carcinoma of the esophagus

- Non-small cell lung cancer

- Ovarian epithelial adenocarcinoma

- Metastatic or unresectable cancer, including any of the following types:

- Breast cancer

- Adenocarcinoma of the colon

- Adenocarcinoma or squamous cell carcinoma of the esophagus

- Hepatoma

- Non-small cell lung cancer

- Small cell lung cancer

- Ovarian epithelial adenocarcinoma

- Adenocarcinoma of the pancreas

- Meets the following criteria (healthy participant):

- No chronic disease

- Healthy participants with a history of cancer must be cancer-free for 5
years (skin cancer or carcinoma in situ of the cervix within the past 5
years allowed)

- Willing to provide 60 mL of blood

- Not a blood relative of an eligible and consenting cancer patient

PATIENT CHARACTERISTICS:

- Able to tolerate the removal of 30-60 mL of blood

- No feelings of light-headedness, dizziness, or fainting within the past 2 weeks

- Pulse less than 100 on day of blood draw for study enrollment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy or radiotherapy for metastatic or
unresectable cancer

- No concurrent chemotherapy

- No concurrent radiotherapy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Identification of tumor antigens that induce a humoral response in cancer patients

Safety Issue:

No

Principal Investigator

Samir M. Hanash, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000276589

NCT ID:

NCT00900094

Start Date:

June 2000

Completion Date:

October 2007

Related Keywords:

Breast Cancer

Colorectal Cancer

Esophageal Cancer

Liver Cancer

Lung Cancer

Ovarian Cancer

Pancreatic Cancer

stage I breast cancer

stage II breast cancer

stage IIIA breast cancer

stage IIIB breast cancer

stage IV breast cancer

adenocarcinoma of the colon

stage I colon cancer

stage II colon cancer

stage III colon cancer

stage IV colon cancer

adenocarcinoma of the esophagus

squamous cell carcinoma of the esophagus

stage I esophageal cancer

stage II esophageal cancer

stage III esophageal cancer

stage IV esophageal cancer

stage I non-small cell lung cancer

stage II non-small cell lung cancer

stage IIIA non-small cell lung cancer

stage IIIB non-small cell lung cancer

stage IV non-small cell lung cancer

stage I ovarian epithelial cancer

stage II ovarian epithelial cancer

stage III ovarian epithelial cancer

stage IV ovarian epithelial cancer

localized unresectable adult primary liver cancer

advanced adult primary liver cancer

adenocarcinoma of the pancreas

stage II pancreatic cancer

stage III pancreatic cancer

extensive stage small cell lung cancer

stage IIIC breast cancer

stage IV pancreatic cancer

recurrent breast cancer

recurrent colon cancer

recurrent esophageal cancer

recurrent non-small cell lung cancer

recurrent ovarian epithelial cancer

recurrent adult primary liver cancer

adult primary hepatocellular carcinoma

recurrent small cell lung cancer

Breast Neoplasms

Colorectal Neoplasms

Esophageal Diseases

Esophageal Neoplasms

Liver Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Pancreatic Neoplasms

Name

Location

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